Kornimate/medical-research-clean huggingface dataset:
a study of jnj-40411813 as supplementary treatment to an antidepressant in adults with depression and anxiety symptoms

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive jnj-40411813 compared to placebo in patients with mdd with anxiety symptoms being treated with an antidepressant.

this is a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled study in adult patients with major depressive disorder (mdd) with anxiety symptoms of relevant severity. the study will consist of 3 phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a 2-week post-treatment (follow up) phase. patients will continue to take the same daily dose of their antidepressant (as directed by the investigator) at the same time of day, from screening through the end of the study, including the post-treatment phase. the total study duration for each patient will be approximately 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder (mdd); patients with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder may be included, if the investigator considers mdd to be the primary diagnosis * a 17-item hamilton depression rating scale (hdrs17) total score =\>18 * a hdrs17 anxiety/somatization factor score =\>7 * is receiving an antidepressant exclusion criteria: * has other psychiatric condition, including, but not limited to, mdd with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia * has a length of current major depressive episode (mde) \>6 months * has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year * not including the inadequate response to the current antidepressant, has more than 1 failed antidepressant treatment of adequate dose and duration in the current mde

Keywords: major depressive disorder depression anxiety symptoms jnj-40411813
european registry for transperineal laser ablation of prostate (tpla) for lower urinary tract symptoms

Conditions: Benign Prostatic Hyperplasia; Prostatic Diseases

Summary: the goal of this observational study is to assess mid- and long-term effectiveness of transperineal laser ablation of prostate (tpla) for the treatment of lower urinary tract symptoms (luts) due to benign prostatic obstruction measured by need and/or time until surgical retreatment. data regarding patient-reported outcomes measures (proms), flowmetry parameters and safety about consecutive patients undergoing tpla will be collected in a dedicated platform. secondary objectives of the study are: * to assess functional and safety outcomes in patients treated with transperineal laser ablation for luts due to benign prostatic obstruction; * to identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of tpla for luts.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * prostate volume ≥ 30 ml; * moderate-to-severe luts according to international prostatic symptoms score (ipss ≥8) * consent to participate; exclusion criteria: * absence of consent; * subsequent withdrawal of consent; * diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance * documented bladder impaired contractility * urethral stenosis * previous prostate surgery

Keywords: tpla transperineal laser ablation luts bph benign prostatic obstruction
effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: albiglutide is an analogue of glucagon-like peptide-1 (glp-1), used to treat type 2 diabetes this study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.


Eligibility criteria:
inclusion criteria: * men or women at least 40 years old. women must be post-menopausal or using a highly effective method for avoidance of pregnancy. * diagnosis of type 2 diabetes. * established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease. * hba1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months). * able and willing to provide informed consent. exclusion criteria: * severely reduced kidney function: egfr \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy. * use of a glp-1 receptor agonist at screening. * severe gastroparesis * history of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study. * personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (men-2). personal history of pancreatic neuroendocrine tumours. * medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study. * breastfeeding, pregnancy, or planning a pregnancy during the course of the study. note: a pregnancy test will be performed on all women of child bearing potential prior to study entry. * known allergy to any glp-1 receptor agonist or excipients of albiglutide. * use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device. * any other reason the investigator deems the subject to be unsuitable for the study.

Keywords: cardiovascular events /outcomes type 2 diabetes mellitus albiglutide glucagon-like peptide-1 receptor agonist
a trial to evaluate the efficacy and safety of multiple combination therapies in participants with chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this is a study designed to evaluate the safety, tolerability and efficacy of new molecular entity (nme) combination therapies in chronic hepatitis b (chb) participants with preserved liver function and without significant fibrosis/cirrhosis. the platform design allows comparison of multiple nme combination therapies against a common control, and introduction of additional treatment arms at later study time points. each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). the safety and efficacy will be monitored throughout the study.


Eligibility criteria:
inclusion criteria: * body mass index between 18 and 32 kg/m2 inclusive. * participants with chronic hepatitis b (chb) infection (hbsag positive for \>=6 months) who are on established nuc (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the same nuc therapy for \>=3 months prior to screening. * hbv dna below the lower lloq or \ 6 months prior to screening and confirmed at screening. * alanine transaminase (alt) \ 6 months prior to screening and confirmed at screening. * female participants: eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods. * male participants: during the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. exclusion criteria: * pregnant or lactating women. * co-infection with other pathogens such as hepatitis a, c, d and e or human immunodeficiency virus (hiv). * history of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease. * history of or suspicion of hepatocellular carcinoma (hcc). * thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests. * clinically significant disease other than chb that, in the opinion of the investigator, makes the participant unsuitable for the study. * pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study. * history of alcohol abuse and/or drug abuse within one year of randomization. * history of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment. * currently taking, or have received within 3 months of day 1, systemic corticosteroids. * electrocardiogram (ecg) with clinically significant abnormalities. * previous treatment with an investigational agent for hepatitis b (hbv) within 6 months prior to screening.
impact of a printed decision aid on cataract surgery choice

Conditions: Age Related Cataracts

Summary: the purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.

shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. the aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy. we will conduct a randomized controlled trial for cataract patients aged 50-80 years. we will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. the primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of age-related cataract; 2. the best corrected visual acuity (bcva) is above 20/60; 3. cataract opacity meets any of the following criterion based on lens opacity classification system (locs) iii: nuclear color and nuclear opalescence is greater than or equal to grade 2 (no2/nc2); cortical opacity is greater than or equal to grade 2 (c2); posterior subcapsular opacity is greater than or equal to grade 2 (p2); 4. willing to know about cataract and cataract surgery; 5. being able to afford cataract surgery; 6. willing to participate in the study and provide the informed content. exclusion criteria: 1. having received cataract surgery; 2. having hearing disorders; 3. having mental disorders; 4. having ocular disorders other than cataract; 5. having surgery contraindication; 6. unwilling to participate in this study.
phase i/ii safety study of ipi-504 in relapsed/refractory stage iiib, or stage iv non-small cell lung cancer (nsclc)

Conditions: Lung Cancer

Summary: the purpose of this study is to determine the safety, tolerability and maximum tolerated dose of ipi-504 in patients with non-small cell lung cancer (nsclc). the study will examine how ipi-504 is absorbed, distributed, metabolized and eliminated by the body. the study will also evaluate the anti-tumor activity of ipi-504.

ipi-504 is a novel small molecule inhibitor of heat shock protein 90 (hsp90), an emerging and recently identified target for cancer therapy. hsp90 is a protein chaperone that plays a central role in maintaining the proper folding, function and viability of various "client proteins". many of the client proteins stabilized by hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. this clinical trial will study the effects of ipi-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of a stage iiib (with malignant pleural or pericardial effusion) or stage iv nsclc * measurable disease by recist criteria. exclusion criteria: * treatment for nsclc with any approved or investigational product within 2 weeks of the start of ipi-504 treatment for any small molecule therapy; within 4 weeks of the start of ipi-504 treatment for any biologic or any conventional chemotherapy. * inadequate hematologic or renal or hepatic function * previous treatment with 17-aag, dmag or other known hsp90 inhibitor.

Keywords: lung cancer cancer of the lung non-small cell lung cancer
diphtheria vaccination in adolescents with inflammatory bowel disease

Conditions: Diphtheria; Inflammatory Bowel Diseases

Summary: assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (porto criteria), * vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6, * written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age. exclusion criteria: * serious exacerbation of inflammatory bowel disease defined as paediatric ulcerative colitis activity index (pucai) \> 65 points for patients with ulcerative colitis or pediatric crohn's disease activity index (pcdai) \> 40 points for patients with crohn's disease.
smoking cessation intervention in acute orthopedic surgery

Conditions: Smoking Cessation; Fracture

Summary: the purpose of this study was to evaluate if an intervention with smoking cessation starting during the acute hospitalization period and continuing during the acute postoperative phase of 6 weeks would reduce the frequency of overall postoperative complications and wound infections in patients with acute musculoskeletal injuries requiring surgical treatment. the secondary aims were to study the short and the long term (1 year) abstinence rate, functional outcome, health related quality of life as well as costs.

tobacco smoking is a major health problem. the effect of a smoking cessation intervention prior to elective orthopedic surgery has been evaluated previously. however, as far as we know there are no prospective randomized studies investigating the effect of smoking cessation on complication rate in patients with acute musculoskeletal injuries.

Eligibility criteria:
inclusion criteria: * daily smoker: more than 2 cigarettes per day for at least one year * acute fracture of an extremity, in need of surgical treatment * oral and written consent exclusion criteria: * pregnancy * alcohol or drug abuse prohibiting compliance with the study protocol * living outside the county of stockholm prohibiting follow-up * a severe mental illness including dementia * inability to read and understand swedish

Keywords: smoking cessation acute injury musculoskeletal postoperative complications
likest study: lipocet® in adults with primary knee osteoarthritis grade 3-4

Conditions: Primary Knee Osteoarthritis Grade 3 - 4

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4

after being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to lipocet ® (once a day, 10 ml corresponding to 1500 mg of cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.

Eligibility criteria:
inclusion criteria: 1. signed patient information sheet and informed consent form 2. patients with primary osteoarthritis classified according to acr/eular criteria 3. men or women aged ≥ 40 and ≤80 years 4. a disease severity grade 3 or 4 according to the kellgren-lawrence classification: * grade 0 (none): definite absence of x-ray changes of osteoarthritis * grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping * grade 2 (minimal): definite osteophytes and possible joint space narrowing * grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends * grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends 5. patients who are candidates for knee replacements can be included (this criterion is not mandatory) 6. patients who mark the pain ≥ 4 cm on a vas 7. patients who are willing or able to follow doctor's instructions 8. patients not participating in other clinical trials within 30 days before the screening 9. patients who have received sufficient explanation for this clinical trial and agreed to participate exclusion criteria: 1. bmi \> 32 2. systemic inflammatory diseases (e.g. fibromyalgia, etc.) 3. progressive serious medical conditions (such as cancer, aids or end-stage renal disease) 4. patients with major infections in the observation period 5. renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values) 6. liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal

Keywords: osteoarthritis lipocet
frailty and dysphagia in older adults

Conditions: Dysphagia; Frailty

Summary: the purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. investigators want to better understand how swallowing problems develop in older adults with and without frailty. identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults. this study will be done at the university of wisconsin-madison (uw-madison). a total of about 69 people will participate in this study.

this study has 3 specific aims: aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults. this proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. this work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study. per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16s rrna gene analysis.

Eligibility criteria:
inclusion criteria: * 65 years of age or older * ability to provide informed consent or the presence of a legally authorized representative (lar) who can consent on behalf of the patient * post-menopausal (female participants) * not pregnant exclusion criteria: * allergy to barium * prior surgery to the head and neck region affecting swallowing-related structures * prior chemotherapy or radiation treatment to the head and neck region * prior cerebral vascular accident with resulting persistent dysphagia * non-english speaking

Keywords: clinical frailty phenotype
assessment of stent malapposition and neointimal coverage on optical coherence tomography at post-procedure and 3 months after platinum chromium alloy of the element™ stent implantation

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (oct) after nominal stent pressure and at a final post-procedure oct (anchor-i) and the neointimal coverage on 3-months oct following the intervention with the randomly assigned two drug-eluting stents (des), promustmelementtm stents versus xience prime® stents.


Eligibility criteria:
inclusion criteria: * patient is ≥ 20 years old * significant coronary de novo lesion (\> 70% by quantitative angiographic analysis) treated by single des in each vessel. * patients with stable angina who are considered for coronary revascularization with stent implantation. * reference vessel diameter of 2.5 to 3.5 mm by operator assessment exclusion criteria: * complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis * reference vessel diameter \ 4.0mm and lesion length \> 28 mm * heavy calcified lesions (definite calcified lesions on angiogram) * lesions requiring more than 2 des in each vessel * acute coronary syndrome * contraindication to anti-platelet agents * treated with any des within 3 months at other vessel * creatinine level ≥ 2.0 mg/dl or esrd * severe hepatic dysfunction (3 times normal reference values) * pregnant women or women with potential childbearing * life expectancy 1 year